OxiMax N-560 Operators Manual Jan 2007

This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 Canada. Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, OxiBand, Dura-Y, MAX-FAST, SatSeconds, PediCheck, Oxismart and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following US patents and foreign equivalents: 4,802,486; 4,869,254; 4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,797; Re 35,122.

Contents Contents... i Figures... v Tables...vi Safety Information... 1 Warnings ...1 Cautions ...1 Notes ...2

Introduction... 3 Intended Use for the N-560 ...3 How to Use this Manual ...3

Description of Controls, Indicators, and Symbols... 5 Identification of Front Panel Buttons and Symbols ...5 Identification of Rear Panel Components ...6 N-560 Symbols ...6 Description of Controls ...7 Description of Displays and Indicators ...9 Interference Explained ...11 Description of Audible Indicators ...13

Setting up the N-560... 15 List of Components ...16 Connecting the N-560 to AC Power ...17 Connecting a Sensor to the N-560 ...17

Battery Operation... 19 Operating the N-560 on Battery Power ...19 Low Battery Indicator ...20

Using the N-560... 21 Turning on the N-560 ...21 Discussion ...21 Procedure ...22 Sensor Attached ...24

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Contents

No Sensor Attached ... 26 Sensor Message ... 26 Setting the Pulse Beep Volume ... 27 Setting the Alarm Volume ... 28 Setting Alarm Silence Duration ... 28 Discussion ... 28 Procedure ... 29 Disabling Audible Alarms ... 30 Discussion ... 30 Procedure ... 31 Verify Patient Settings ... 32 Alarm Limits Changed Indicator ... 34 Setting Alarm Limits ... 34 Discussion ... 34 Procedure ... 34 Setting SatSeconds Duration ... 37 Discussion ... 37 Procedure ... 37 Setting the Data Port Baud Rate ... 37 Discussion ... 37 Procedure ... 38 Setting the Data Port Protocol ... 39 Clearing Trend Information ... 40

N-560 Trend... 43 Trend Data Operation ... 43 Trend Data ... 44 #1: Trend Print ... 44 #2: Trend Clear ... 44 #3: Not Used ... 44 #4: Baud Rate ... 44 #5: Data Port Printout ... 45 Option 1 ... 45 Option 2 ... 45

Using the Data Port... 47 Overview ... 47

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Contents

Connecting to the Data Port ...47 Data Port Pinouts ...48 Data Port Setup ...49 Discussion ...49 Procedure ...49 Nurse Call Interface ...53 Setting Nurse Call RS-232 Polarity ...54 Setting Nurse Call Relays Normally Open/Closed ...54

Printing... 55 Printing N-560 Real-Time Data ...55 Trend Data Printout ...57 Column Headings ...58 Data Source ...58 Device/Software Revision Level ...58 Alarm Limits ...58 N-560 Mode ...59 Data Column Headings ...59 Time ...59 Patient Data ...60 Operating Status ...60

Sensors and Accessories... 63 Selecting a Sensor ...63 Biocompatibility Testing ...66 Optional Accessories ...66 Visual Alarm Indicator ...66 Pole Mount Bracket ...67

Performance Considerations... 69 Performance Verification ...69 N-560 Performance Considerations ...69 Dysfunctional Hemoglobins ...69 Anemia ...70 Saturation ...70 Pulse rates ...70 Sensor Performance Considerations ...70

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Contents

Operator’s Menu...73 Troubleshooting...75 Error Codes ... 75 Corrective Action ... 76 EMI (Electro-magnetic Interference) ... 79 Obtaining Technical Assistance ... 80

Maintenance...83 Returning the N-560 ... 83 Service ... 83 Periodic Safety Checks ... 83 Cleaning ... 84

Technical Information... 85 Description of Alarms ... 85 Factory Defaults ... 86 SatSeconds Display ... 87 Describing SatSeconds ... 87 SatSeconds “Safety Net” ... 89

Principles of Operation... 91 Oximetry Overview ... 91 Automatic Calibration ... 92 Functional versus Fractional Saturation ... 93 Measured versus Calculated Saturation ... 93 Functional Testers and Patient Simulators ... 94

Specifications... 95 Performance ... 95 Electrical ... 99 Environmental Conditions ... 100 Physical Characteristics ... 101 Compliance ... 102 Manufacturer’s Declaration ... 103

Index... 111

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Figures Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7:

Front Panel Buttons and Symbols ... 5 Rear Panel Symbols ... 6 Data Port Pin Layout ... 49 Real-Time Data Printout ... 56 Trend Data Printout ... 57 Alarm Response with SatSeconds ... 89 Oxyhemoglobin Dissociation Curve ... 93

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Ta b l e s Table 1: Data Port Pinouts ...48 Table 2: Nellcor Oximetry Sensor Models and Patient Weights ...64 Table 3: Operator’s Menu ...73 Table 4: Error Codes ...76 Table 5: Factory Default Settings ...86 Table 6: Tone Definition ...96 Table 7: Cable Compliance ...104 Table 8: Electromagnetic Emissions ...105 Table 9: Electromagnetic Immunity ...106 Table 10: Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and the N-560 ...109

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Safety Information Warnings

Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes (death, injury, or adverse events) to the patient or user. WARNING: Explosion hazard. Do not use the N-560™ pulse oximeter in the presence of flammable anesthetics or gases.

WARNING: Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions, sensor application errors, and certain patient conditions. See the appropriate sections of the manual for specific safety information.

WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone.

Cautions

Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the N-560.

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Safety Information CAUTION: When connecting the N-560 to any instrument, verify proper operation before clinical use. Both the N-560 and the instrument connected to it must be connected to a grounded outlet. Accessory equipment connected to the N-560's data interface must be certified according to IEC Standard 60950 for data-processing equipment or IEC Standard 60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Anyone who connects additional equipment to the signal input port or signal output port (N-560 data port connector) configures a medical system and is therefore responsible for ensuring that the system complies with the requirements of system standard IEC Standard 60601-1-1 and the electromagnetic compatibility system standard IEC Standard 60601-1-2. The N-560 accuracy may degrade if it is connected to secondary I/O devices when the instrument is not connected to earth reference. CAUTION: Do not lift the N-560 by the sensor cable or power cord because the cable or cord could disconnect from the N-560, causing damage to the N-560 or injuring the patient. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Notes

Notes are identified by the Note symbol shown above. Notes provide additional useful information. Note: Sensor LED light emissions fall within Class 1 level, according to IEC 60825-1:2001. No special safety precautions are required.

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Introduction

Introduction

WARNING: The N-560 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. Do not make any clinical judgments based on the oximeter's measurements only.

Intended Use for the N-560 The N-560 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-560 is intended for use with neonatal, pediatric, and adult patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only. Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility. Use with any particular patient requires the selection of an appropriate oxygen transducer (sensor) as described in this Operator's Manual.

How to Use this Manual All users should read this manual thoroughly. More experienced users of the N-560 can directly go to topics for the information they require. This manual is available on the internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html

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Introduction

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Description of Controls, Indicators, and Symbols

Description of Controls, Indicators, and Symbols Identification of Front Panel Buttons and Symbols

Figure 1: Front Panel Buttons and Symbols 1. SpO2 Sensor Port

12. SatSeconds Alarm Limit Button

2. Power On/Off Button

13. SpO2 Alarm Limit Button

3. %SpO2 Display

14. Interference Indicator

4. Pulse Amplitude Indicator

15. Sensor Off Indicator

5. Pulse Rate Display

16. Sensor Message Indicator

6. Alarm Silence Button

17. Pulse Search Indicator

7. Alarm Silence Indicator

18. Data In Sensor Indicator

8. Adjust Up Button

19. Low Battery Indicator

9. Adjust Down Button

20. AC Power Indicator

10. Pulse Rate Alarm Limit Button

21. Speaker

11. SatSecondsTM Display

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Description of Controls, Indicators, and Symbols

Identification of Rear Panel Components

1. Data Port Connector

3. AC Power Connector

2. Visual Alarm Connector

4. Equipotential Connector (ground)

Figure 2: Rear Panel Symbols

N-560 Symbols The symbols that are located on the rear panel of the N-560 are as follows:

1. Data Interface 2. Caution - Do not connect while power is on

3. Equipotential Terminal (ground)

The symbols that are located on the front panel of the N-560 are as follows: 6

Description of Controls, Indicators, and Symbols

1. Type BF Applied Part - Not Defibrillator Proof

6. Pulse Search

2. Pulse Rate

7. Data In Sensor

3. Interference

8. Low Battery

4. Sensor Off

9. AC Power/Battery Charge

5. Sensor Message

Description of Controls

Note: Each button press, except the Power On/Off button, should result in either a valid or an invalid button tone. If the button pressed fails to emit a tone, contact qualified service personnel. The Power On/Off button is used to turn the N-560 on or off.

The Alarm Silence button is used to silence current alarms for the alarm silence duration period. When an alarm has been silenced, pressing the button again reactivates, or “unsilences” the alarm. It is also used to view and adjust alarm silence duration and alarm volume.

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Description of Controls, Indicators, and Symbols The Adjust Up button is used to increase alarm limit values, alarm silence duration, pulse beep volume, alarm volume, and data port baud rate. The Adjust Up button is used to select the communication protocol and time settings. Press the Adjust Up button one time to increase the display by one digit. Holding the Adjust Up button down for more than one second cause the display digits to scroll. The Adjust Down button is used to decrease alarm limit values, alarm silence duration, pulse beep volume, alarm volume, and data port baud rate. The Adjust Down button is used to select the communication protocol and time settings. Press the Adjust Down button one time to decrease the display by one digit. Holding the Adjust Down button down for more than one second cause the display digits to scroll. The SpO2 Alarm Limit button is used to view the SpO2 alarm limit. When the SpO2 Alarm Limit button is pressed at the same time as the Pulse Rate Alarm Limit button for approximately three seconds, the menu options are enabled. The Pulse Rate Alarm Limit button is used to view the pulse rate alarm limit. When the Pulse Rate Alarm Limit button is pressed at the same time as the SpO2 Alarm Limit button for approximately three seconds, the menu options are enabled. The SatSeconds Alarm Limit button is used to view the SatSeconds alarm limit. When pressed, the SatSeconds limit options are enabled. The Adjust Up and Adjust Down buttons are used to change the SatSeconds limit settings.

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Description of Controls, Indicators, and Symbols

Description of Displays and Indicators

The Pulse Amplitude Indicator (blip bar). A 10-segment LED that indicates pulse beat and shows the relative (non-normalized) pulse amplitude. As the detected pulse becomes stronger, more bars light with each pulse.

The %SpO2 Display. Shows the saturation level of oxygenated hemoglobin. The display value flashes zero during loss-of-pulse alarms and flashes the SpO2 value in red when the SpO2 is outside the alarm limits. During pulse search, the N-560 continues to update the display. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the SpO2 value (100.). The Pulse Rate Display. Shows the pulse rate in beats per minute. It flashes zeros during loss-of-pulse alarms and flashes the beats per minute value in red when the pulse rate is outside of the alarm limit. During pulse search, the N-560 continues to update the display. Pulse rates outside of the pulse rate range (20 to 250 bpm) are displayed as the closest value within the range. If alarm limits have been changed from their power-on defaults, a decimal point (.) is displayed after the pulse rate value (112.). The AC Power Indicator. Lights continuously when the N-560 is connected to AC power. It also indicates that the battery is charging. It is off when the N-560 is being powered by its internal battery. The Low Battery Indicator. Lights continuously to indicate that 15 or fewer minutes of battery capacity remain. The Low Battery indicator flashes when the battery is critically low.

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Description of Controls, Indicators, and Symbols The Alarm Silence Indicator. Lights continuously when an audible alarm has been silenced. It flashes when the alarm silence duration has been set to OFF. The Interference Indicator. Lights whenever the OXIMAX software detects that the incoming signal quality is degraded due to interference (see Interference Explained on page 11). An intermittently lit Interference indicator is common during patient monitoring, and indicates that the OXIMAX algorithm is dynamically adjusting the amount of data required for measuring SpO2 and Pulse Rate. When lit continuously, it indicates that the OXIMAX algorithm has extended the amount of data required for measuring SpO2 and Pulse Rate, and, consequently, fidelity in tracking rapid changes in these values may be reduced (see Description of Displays and Indicators on page 9). The Pulse Search Indicator. Lights continuously prior to initial acquisition of a pulse signal and during prolonged and challenging monitoring conditions. It flashes during a loss-of-pulse signal. The Sensor Off Indicator is lit when either the sensor is invalid, or no longer on the patient’s finger. It usually indicates that the sensor is not on the patient. The Sensor Message Indicator. Lights when the N-560 cannot determine an SpO2 level or a pulse rate. The sensor message recommendations for improving the signal are:

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•

Reposition sensor

•

Check or change adhesive wrap

•

Choose alternate site

•

Warm site

•

Cover sensor

•

Use forehead, nasal, or ear sensor (adult patients only)

•

Use OXIMAX adhesive sensor

•

Secure cable

•

Secure with headband (MAX-FAST)

•

Remove nail polish

Description of Controls, Indicators, and Symbols •

Loosen sensor (too tight)

•

Isolate external interference (electrosurgical device, cell phone)

•

Clean site (MAX-R)

The Data In Sensor Indicator. The indicator blinks for approximately one minute when initially connected to the N-560 to indicate that the attached OXIMAX sensor contains a patient sensor event record. The indicator lights continuously to indicate that the attached sensor memory is full. The indicator does not light when there is no data in the sensor, even though a valid sensor is connected to the N-560. The SatSecondsTM Indicator. Fills in clockwise as the SatSeconds alarm management approaches the SatSeconds alarm limit threshold. All segments of the SatSeconds indicator flash during a SatSeconds alarm. When a SatSeconds setting other than OFF is selected, the green LED at the top of the SatSeconds indicator will light. The green LED at the 12-o'clock position indicates that SatSeconds alarm management is engaged.

Interference Explained Interference is a term that was formally introduced in ISO9919:2005, “Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use”. Interference may arise from a number of sources, alone or in combination, and the term refers to the effects on the incoming red and IR signals caused by physiological conditions, medical procedures, or external agents. The effect of interference on a pulse oximeter is due only to the amount of interference, and is generally nondiscriminatory as to its source. Interference may or may not affect the accuracy of measurements, depending upon its severity, nature, or duration. Factors which may result in interference include but are not limited to:

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Description of Controls, Indicators, and Symbols

• incorrect sensor application – sensor placement on an extremity with a blood pressure cuff, arterial catheter, or intravascular line – sensor applied too tightly – incorrect sensor for placement site • intravascular dyes, such as indocyanine green or methylene blue • externally applied coloring agents, such as nail polish, dye, or pigmented cream • failure to cover the sensor with opaque material in high ambient light conditions, for example, conditions created from one or more of the following sources: – surgical lights, especially xenon light sources – bilirubin lamps – fluorescent lights – infrared heating lamps – direct sunlight • physical movement, either patient or imposed activity • venous pulsation • dysfunctional hemoglobin • low perfusion • intermittent pulsatility or arrhythmia • electromagnetic interference (EMI) • ventilator-induced pressure changes

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